New U.S. Veterinary Biological Establishment Licenses and Permits (new permittees) were issued as

follows:

________________________________________________________________

New U.S. Veterinary Biologics Product Licenses and Biological Product Permits (new codes) were

issued as follows:

________________________________________________________________

There were no U.S. Veterinary Biologics Establishment Licenses or Permits (Permittees) terminated

this quarter.

United States Department of Agriculture

Animal and Plant

Health Inspection

Services

Veterinary Services

Center for Veterinary

Biologics

1920 Dayton Ave

PO Box 844

Ames, IA 50010

(515) 337-6100

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 18-06

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron Rippke

Director

SUBJECT: Issuance of Licenses

The purpose of this notice is to bring to the attention of interested parties licenses issued and

terminated between January 01, 2018 and March 31, 2018. These do not include those licenses

reissued to update pertinent information.

Est. Name and Address Est. No. Type

Medgene Labs

Brookings, SD

474 Licensee

True Name Code Est. Name/No.

Autogenous Bacterin 2051.00 Medgene Labs/Est No. 474

Avian Paramyxovirus Vaccine, Type 1, Killed Virus 10C5.11 Arko Laboratories Ltd./Est No. 337

Bordetella Bronchiseptica Vaccine, Avirulent Live Culture 1081.01 Merial, Inc./Est No. 298

Bursal Disease-Marek's Disease-Newcastle Disease Vaccine, Serotype 3, Live

Marek's Disease Vector

1A89.R0 Biomune Company/Est No. 368

Bursal Disease-Marek's Disease-Newcastle Disease Vaccine, Serotypes 2 & 3,

Live Virus, Live Marek's Disease Vector

1A91.R0 Biomune Company/Est No. 368

Canine Heartworm Antigen-Anaplasma-Borrelia Burgdorferi-Ehrlichia Antibody

Test Kit

5P23.00 SA Scientific, Ltd./Est No. 373

Escherichia Coli Vaccine, Avirulent Live Culture 1551.02 Diamond Animal Health, Inc./Est No.

213

Marek's Disease Vaccine, Serotype 2, Live Virus 1631.04 Merial, Inc./Est No. 298

Marek's Disease Vaccine, Serotype 3, Live Virus 1641.05 Merial, Inc./Est No. 298

Mycoplasma Hyorhinis Bacterin 27H8.00 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Newcastle-Bronchitis Vaccine, B1 Type, B1 Strain, Mass & Conn Types, Live

Virus

1762.1J Merial, Inc./Est No. 298

Porcine Circovirus Vaccine, Type 1 -Type 2 Chimera, Killed Virus, Mycoplasma

Hyopneumoniae Bacterin

49K5.R7 Zoetis Inc./Est No. 190

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 18-06

Page 2

________________________________________________________________

U.S. Veterinary Biological Product Licenses and Permits (codes) were terminated without prejudice

as follows:

________________________________________________________________

True Name Code Est. Name/No.

Avian Encephalomyelitis Vaccine, Live Virus 1051.11 Elanco US Inc./Est No. 196

Bovine Rhinotracheitis-Parainfluenza 3 Vaccine, Killed Virus, Mannheimia

Haemolytica-Pasteurella Multocida Bacterin

4265.00 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Bovine Rhinotracheitis-Parainfluenza 3 Vaccine, Modified Live Virus 1121.20 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus

1181.23 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus, Haemophilus Somnus Bacterin

44C9.20 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus, Haemophilus Somnus Bacterin

44C9.23 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus, Haemophilus Somnus-Leptospira CanicolaGrippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

44D9.23 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus, Leptospira Canicola-GrippotyphosaHardjo-Icterohaemorrhagiae-Pomona Bacterin

4469.23 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Bovine Virus Diarrhea Vaccine, Modified Live Virus 1201.20 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Brucella Abortus, Killed Culture E013.02 Colorado Serum Company/Est No. 188

Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live Virus 1A82.50 Zoetis Inc./Est No. 190

Canine Distemper-Hepatitis-Parainfluenza Vaccine, Modified Live Virus 1381.21 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Canine Distemper-Hepatitis-Parainfluenza-Parvovirus Vaccine, Modified Live

Virus, Leptospira Canicola-Icterohaemorrhagiae Bacterin

47P9.22 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Encephalomyelitis Vaccine, Eastern & Western & Venezuelan, Killed Virus,

Tetanus Toxoid

4865.27 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Encephalomyelitis Vaccine, Eastern & Western & Venezuelan, Killed Virus,

Tetanus Toxoid

4867.21 Zoetis Inc./Est No. 190

Encephalomyelitis Vaccine, Eastern & Western, Killed Virus 1485.20 Colorado Serum Company/Est No. 188

Encephalomyelitis Vaccine, Eastern & Western, Killed Virus, Tetanus Toxoid 4865.20 Colorado Serum Company/Est No. 188

Encephalomyelitis Vaccine, Eastern & Western, Killed Virus, Tetanus Toxoid 4865.26 Zoetis Inc./Est No. 190

Encephalomyelitis Vaccine, Eastern & Western, Killed Virus, Tetanus Toxoid 4865.21 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Encephalomyelitis-Influenza Vaccine, Eastern & Western & Venezuelan, Killed

Virus, Tetanus Toxoid

4875.23 Zoetis Inc./Est No. 190

Encephalomyelitis-Influenza Vaccine, Eastern & Western, Killed Virus, Tetanus

Toxoid

4835.23 Zoetis Inc./Est No. 190

Encephalomyelitis-Rhinopneumonitis-Influenza Vaccine, Eastern & Western &

Venezuelan, Killed Virus, Tetanus Toxoid

4847.23 Zoetis Inc./Est No. 190

Encephalomyelitis-Rhinopneumonitis-Influenza Vaccine, Eastern & Western,

Killed Virus, Tetanus Toxoid

4845.23 Zoetis Inc./Est No. 190

Encephalomyelitis-West Nile Virus Vaccine, Eastern & Western & Venezuelan,

Killed Virus, Tetanus Toxoid

48W5.23 Zoetis Inc./Est No. 190

Encephalomyelitis-West Nile Virus Vaccine, Eastern & Western, Killed Virus,

Tetanus Toxoid

48W5.22 Zoetis Inc./Est No. 190

Haemophilus Parasuis Vaccine, Avirulent Live Culture A9J1.00 Newport Laboratories, Inc./Est No. 455

Haemophilus Parasuis Vaccine, Avirulent Live Culture 19J1.01 Newport Laboratories, Inc./Est No. 455

Haemophilus Parasuis Vaccine, Avirulent Live Culture, Mycoplasma

Hyopneumoniae Bacterin

4A79.00 Newport Laboratories, Inc./Est No. 455

Mycoplasma Hyopneumoniae Bacterin 2775.00 Newport Laboratories, Inc./Est No. 455

Parvovirus Vaccine, Modified Live Virus, Leptospira CanicolaIcterohaemorrhagiae Bacterin4960.00 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Tetanus Toxoid 8601.01 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Tetanus Toxoid 8601.03 Zoetis Inc./Est No. 190

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 18-06

Page 3

There were no Product Licenses or Permits (codes) issued due to an acquisition this quarter.

An Equal Opportunity Provider and Employer